RECRUITING

A Clinical Investigation Evaluating Wound Closure With OptiPulse™ Versus SOC in the Treatment of Non-Healing DFU's

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this clinical investigation is to assess the safety and performance of Compedica's OptiPulse™ and to collect subject outcome data on the treatment of diabetic foot ulcers (DFU's) versus the standard of care (SOC). OptiPulse™ is designed to enhance blood circulation in the venules and arterioles. Fibracol Plus (or equivalent) is a collagen alginate dressing that is used as the primary dressing. Both products are 510(k) FDA cleared and will be used within the cleared intended use.

Official Title

A Multi-center, Randomized Controlled Clinical Investigation Evaluating Wound Closure With OptiPulse™ Versus Standard of Care in the Treatment of Non-Healing Diabetic Foot Ulcers

Quick Facts

Study Start:2021-12-15

Study Completion:2024-12-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05193929

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. At least 18 years old, inclusive. 2. Presence of a DFU, Wagner Grade 1 (see Appendix A for definitions) on the plantar or dorsal aspect of the foot, extending through the dermis provided it is below the medial aspect of the malleolus. 3. The index ulcer will be the largest ulcer if two or more DFUs are present with the same Wagner grade and will be the only one evaluated in the study. If other ulcerations are present on the same foot, they must be more than 2 cm distant from the index ulcer. 4. Index ulcer (i.e. current episode of ulceration) has been present for greater than 4 weeks prior to SV1 and less than 1 year, as of the date the subject consents for study. 5. Index ulcer is a minimum of 0.8 cm2 and a maximum of 25 cm2 at SV1 and TV1. 6. Within 3 months of SV1, adequate circulation to the affected foot, as documented by a dorsal transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 30 mmHg, or an Ankle Branchial Index (ABI) between 0.7 and 1.3 within 3 months of SV1, using the affected study extremity. As an alternative arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle or a TBI (Toe Brachial Index) of \> 0.6 is acceptable. 7. The target ulcer has been offloaded for at least 14 days prior to randomization. 8. Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers or abstinence) during the course of the study and undergo pregnancy tests. 9. Subject understands and is willing to participate in the clinical study and can comply with weekly visits. 10. Subjects must have read and signed the IRB approved ICF before screening procedures are performed.	* 1. Index ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes. 2. Index ulcer, in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer. 3. Index ulcer is overtly infected (i.e. purulent drainage). 4. Subjects with a history of more than two weeks of treatment with immune-suppressants (including systemic corticosteroids \>10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within 1-month prior to first SV1, or who receive such medications during the screening period or who are anticipated to require such medications during the course of the study. 5. Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding SV1. 6. History of radiation at the ulcer site (regardless of time since last radiation treatment). 7. Index ulcer has been previously treated or will need to be treated with any prohibited therapies. 8. Subjects with a previous diagnosis of HIV or Hepatitis C. 9. Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence with medical treatment. 10. Osteomyelitis or bone infection of the affected foot as verified by x-ray within 30 days prior to the first screening visit. (In the event of an ambiguous diagnosis, the Principal Investigator will make the final decision). 11. Subject is pregnant or breast-feeding. 12. Presence of diabetes with poor metabolic control as documented with an HbA1c \>12.0 within last 90 days. 13. Subjects with end-stage renal disease as evidenced by a serum creatinine ≥3.0 mg/dL within 6 months of randomization. 14. Presence of active Charcot Neuroarthropathy to the affected limb. 15. Any wound located entirely on the medial or lateral border of the foot. 16. Any wound located between the 1st through 4th toe interspaces. 17. Index ulcer has reduced in area by 30% or more after 14 days of SOC from SV1 to the TV1/Randomization visit.

Inclusion Criteria

Exclusion Criteria

1. At least 18 years old, inclusive.
2. Presence of a DFU, Wagner Grade 1 (see Appendix A for definitions) on the plantar or dorsal aspect of the foot, extending through the dermis provided it is below the medial aspect of the malleolus.
3. The index ulcer will be the largest ulcer if two or more DFUs are present with the same Wagner grade and will be the only one evaluated in the study. If other ulcerations are present on the same foot, they must be more than 2 cm distant from the index ulcer.
4. Index ulcer (i.e. current episode of ulceration) has been present for greater than 4 weeks prior to SV1 and less than 1 year, as of the date the subject consents for study.
5. Index ulcer is a minimum of 0.8 cm2 and a maximum of 25 cm2 at SV1 and TV1.
6. Within 3 months of SV1, adequate circulation to the affected foot, as documented by a dorsal transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 30 mmHg, or an Ankle Branchial Index (ABI) between 0.7 and 1.3 within 3 months of SV1, using the affected study extremity. As an alternative arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle or a TBI (Toe Brachial Index) of \> 0.6 is acceptable.
7. The target ulcer has been offloaded for at least 14 days prior to randomization.
8. Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers or abstinence) during the course of the study and undergo pregnancy tests.
9. Subject understands and is willing to participate in the clinical study and can comply with weekly visits.
10. Subjects must have read and signed the IRB approved ICF before screening procedures are performed.

* 1. Index ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes.
2. Index ulcer, in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer.
3. Index ulcer is overtly infected (i.e. purulent drainage). 4. Subjects with a history of more than two weeks of treatment with immune-suppressants (including systemic corticosteroids \>10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within 1-month prior to first SV1, or who receive such medications during the screening period or who are anticipated to require such medications during the course of the study.
5. Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding SV1.
6. History of radiation at the ulcer site (regardless of time since last radiation treatment).
7. Index ulcer has been previously treated or will need to be treated with any prohibited therapies.
8. Subjects with a previous diagnosis of HIV or Hepatitis C. 9. Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence with medical treatment.
10. Osteomyelitis or bone infection of the affected foot as verified by x-ray within 30 days prior to the first screening visit. (In the event of an ambiguous diagnosis, the Principal Investigator will make the final decision).
11. Subject is pregnant or breast-feeding. 12. Presence of diabetes with poor metabolic control as documented with an HbA1c \>12.0 within last 90 days.
13. Subjects with end-stage renal disease as evidenced by a serum creatinine ≥3.0 mg/dL within 6 months of randomization. 14. Presence of active Charcot Neuroarthropathy to the affected limb. 15. Any wound located entirely on the medial or lateral border of the foot. 16. Any wound located between the 1st through 4th toe interspaces. 17. Index ulcer has reduced in area by 30% or more after 14 days of SOC from SV1 to the TV1/Randomization visit.

Contacts and Locations

Study Contact

Daniel Blackman

CONTACT

+44 (0)7809144960

Daniel.blackman@Compedica.com

Study Locations (Sites)

Titan Clinical Research

Phoenix, Arizona, 85004

United States

Felix Sigal

Los Angeles, California, 90010

United States

Clemente Clinical Research

Los Angeles, California, 90033

United States

ILD Research

Vista, California, 92083

United States

Midland Florida clinical Research Center LLC

DeLand, Florida, 32720

United States

Integral Clinical Trial Solutions

Homestead, Florida, 33030

United States

Integral Clinical Trials Solutions

Pembroke Pines, Florida, 33026

United States

Integral Clinical Trials Solutions

Tamarac, Florida, 33321

United States

Viable Research Management

Las Vegas, Nevada, 89120

United States

Foot Associates of New York

New York, New York, 10022

United States

Foot & Ankle specialists of the Mid-Atlantic

Gastonia, North Carolina, 28054

United States

Foot & Ankle Specialists of the Mid-Atlantic

Raleigh, North Carolina, 27609

United States

Lower Extremity Institution of Research and Therapy (LEIRT)

Boardman, Ohio, 44512

United States

Mt. Olympus Medical Research

Houston, Texas, 77054

United States

Clinical Trials Network

Houston, Texas, 77074

United States

Foot and Ankle Specialist of the Mid-Atlantic - Roanoke

Roanoke, Virginia, 24016

United States

Foot and Ankle Specialist of the Mid-Atlantic - Salem

Salem, Virginia, 24153

United States

Salem Research institute

Salem, Virginia, 24153

United States

Collaborators and Investigators

Sponsor: Compedica Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-15

Study Completion Date2024-12-15

Study Record Updates

Study Start Date2021-12-15

Study Completion Date2024-12-15

Terms related to this study

Additional Relevant MeSH Terms

Diabetic Foot Ulcer